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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTELLECT CRANIAL NAVIGATION SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO INTELLECT CRANIAL NAVIGATION SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number VERSION 1.1-14
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 12/11/2015
Event Type  malfunction  
Event Description
It was reported that during a transsphenodal pituitary tumor resection the procedure was aborted at the discretion of the surgeon, as the accuracy was off approximately 1 to 2 mm inferiorly.The procedure once again attempted and completed after approximately 1 to 2 hours, without the use of navigation.There were no adverse consequences or medical interventions reported with this event.
 
Event Description
It was reported that during a transsphenoidal pituitary tumor resection the procedure was aborted at the discretion of the surgeon, as the accuracy was off approximately 1 to 2 mm inferiorly.The procedure once again attempted and completed after approximately 1 to 2 hours, without the use of navigation.There were no adverse consequences or medical interventions reported with this event.
 
Manufacturer Narrative
The reported event of inaccuracy of about 1-2 mm can be confirmed based on log file review.It was identified that the customer used a registration mask for registration and as a patient tracker for navigation, which cause or contribute to the small inaccuracy.
 
Event Description
It was reported that during a transsphenoidal pituitary tumor resection the procedure was aborted at the discretion of the surgeon, as the accuracy was off approximately 1 to 2 mm inferiorly.The procedure once again attempted and completed after approximately 1 to 2 hours, without the use of navigation.There were no adverse consequences or medical interventions reported with this event.
 
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Brand Name
INTELLECT CRANIAL NAVIGATION SOFTWARE
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5356704
MDR Text Key35537039
Report Number0001811755-2016-00036
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062640
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVERSION 1.1-14
Device Catalogue Number6000-651-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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